Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
congenital heart defect
Item
congenital heart defect
boolean
C0018798 (UMLS CUI 2011AA)
13213009 (SNOMED CT 2011_0131)
10002626 (MedDRA 14.1)
Q24.9 (ICD-10-CM Version 2010)
746.9 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
morphologic heart failure of the right or left system ventricle with an ejection fraction of absolute <= 40%
Item
morphologic heart failure of the right or left system ventricle with an ejection fraction of absolute <= 40%
boolean
C0332437 (UMLS CUI 2011AA)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0225897 (UMLS CUI 2011AA)
87878005 (SNOMED CT 2011_0131)
MTHU001535 (LOINC Version 232)
C0225883 (UMLS CUI 2011AA)
53085002 (SNOMED CT 2011_0131)
MTHU001537 (LOINC Version 232)
C0232174 (UMLS CUI 2011AA)
70822001 (SNOMED CT 2011_0131)
C0205344 (UMLS CUI 2011AA)
56136002 (SNOMED CT 2011_0131)
NYHA II - IV
Item
NYHA II - IV
boolean
C1319794 (UMLS CUI 2011AA)
421704003 (SNOMED CT 2011_0131)
10064080 (MedDRA 14.1)
C1319795 (UMLS CUI 2011AA)
420913000 (SNOMED CT 2011_0131)
10064081 (MedDRA 14.1)
C1319796 (UMLS CUI 2011AA)
422293003 (SNOMED CT 2011_0131)
10064082 (MedDRA 14.1)
optimal drug therapy for heart failure according to the ESC guidelines
Item
optimal drug therapy for heart failure according to the ESC guidelines
boolean
C2698651 (UMLS CUI 2011AA)
CL428482 (UMLS CUI 2011AA)
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0680240 (UMLS CUI 2011AA)
C1535514 (UMLS CUI 2011AA)
414152003 (SNOMED CT 2011_0131)
2108-9 (HL7 V3 2006_05)
C0037459 (UMLS CUI 2011AA)
C0007189 (UMLS CUI 2011AA)
394579002 (SNOMED CT 2011_0131)
C0220845 (UMLS CUI 2011AA)
QRS-interval >= 120 ms (according to at least two ECG)
Item
QRS-interval >= 120 ms (according to at least two ECG)
boolean
C0520880 (UMLS CUI 2011AA)
39632005 (SNOMED CT 2011_0131)
C0680240 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above mentioned criteria
Item
chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above mentioned criteria
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C1292856 (UMLS CUI 2011AA)
122545008 (SNOMED CT 2011_0131)
C0446978 (UMLS CUI 2011AA)
244380000 (SNOMED CT 2011_0131)
C0018827 (UMLS CUI 2011AA)
21814001 (SNOMED CT 2011_0131)
MTHU024371 (LOINC Version 232)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0018827 (UMLS CUI 2011AA)
21814001 (SNOMED CT 2011_0131)
MTHU024371 (LOINC Version 232)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
morphologically right ventricle in system position and significant insufficiency of the systemic AV valve, which also meets the above mentioned criteria
Item
morphologically right ventricle in system position and significant insufficiency of the systemic AV valve, which also meets the above mentioned criteria
boolean
C0332437 (UMLS CUI 2011AA)
116676008 (SNOMED CT 2011_0131)
MTHU008051 (LOINC Version 232)
C0225883 (UMLS CUI 2011AA)
53085002 (SNOMED CT 2011_0131)
MTHU001537 (LOINC Version 232)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
C0450429 (UMLS CUI 2011AA)
246267002 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0231179 (UMLS CUI 2011AA)
87828008 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0225924 (UMLS CUI 2011AA)
11124005 (SNOMED CT 2011_0131)
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
electromechanic dyssynchrony as defined in study protocol
Item
electromechanic dyssynchrony as defined in study protocol
boolean
CL428819 (UMLS CUI 2011AA)
10071186 (MedDRA 14.1)
C1704788 (UMLS CUI 2011AA)
C2348563 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
PTCA, cardiomyoplasty, myocardium infarction, instable angina pectoris or cerebral insult within 6 weeks before the planned cardiac resynchronization therapy
Item
PTCA, cardiomyoplasty, myocardium infarction, instable angina pectoris or cerebral insult within 6 weeks before the planned cardiac resynchronization therapy
boolean
C2936173 (UMLS CUI 2011AA)
11101003 (SNOMED CT 2011_0131)
10050339 (MedDRA 14.1)
C0242637 (UMLS CUI 2011AA)
C0027051 (UMLS CUI 2011AA)
22298006 (SNOMED CT 2011_0131)
10028596 (MedDRA 14.1)
MTHU035551 (LOINC Version 232)
I21-I22 (ICD-10-CM Version 2010)
410 (ICD-9-CM Version 2011)
E10152 (CTCAE 1105E)
C0002965 (UMLS CUI 2011AA)
4557003 (SNOMED CT 2011_0131)
10002388 (MedDRA 14.1)
I20.0 (ICD-10-CM Version 2010)
411.1 (ICD-9-CM Version 2011)
C0038454 (UMLS CUI 2011AA)
230690007 (SNOMED CT 2011_0131)
10042244 (MedDRA 14.1)
I63.9 (ICD-10-CM Version 2010)
E12826 (CTCAE 1105E)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C1167956 (UMLS CUI 2011AA)
10059862 (MedDRA 14.1)
pulmonary hypertension/Eisenmenger syndrome
Item
pulmonary hypertension/Eisenmenger syndrome
boolean
C0020542 (UMLS CUI 2011AA)
70995007 (SNOMED CT 2011_0131)
10037400 (MedDRA 14.1)
I27.2 (ICD-10-CM Version 2010)
E13539 (ICD-9-CM Version 2011)
C0013743 (UMLS CUI 2011AA)
445928005 (SNOMED CT 2011_0131)
10058554 (MedDRA 14.1)
I27.89 (ICD-10-CM Version 2010)
univentricular heart without Fontan procedure
Item
univentricular heart without Fontan procedure
boolean
C0152424 (UMLS CUI 2011AA)
45503006 (SNOMED CT 2011_0131)
10045545 (MedDRA 14.1)
Q20.4 (ICD-10-CM Version 2010)
745.3 (ICD-9-CM Version 2011)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0190010 (UMLS CUI 2011AA)
56527009 (SNOMED CT 2011_0131)
life expectancy less than 1 year due to a non-cardiac disease
Item
life expectancy less than 1 year due to a non-cardiac disease
boolean
C0023671 (UMLS CUI 2011AA)
LP75025-4 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
CL420107 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0018799 (UMLS CUI 2011AA)
56265001 (SNOMED CT 2011_0131)
10061024 (MedDRA 14.1)
expected poor compliance of the patient, e.g. Trisomic 21 or other mental retardation
Item
expected poor compliance of the patient, e.g. Trisomic 21 or other mental retardation
boolean
C1517001 (UMLS CUI 2011AA)
C0032646 (UMLS CUI 2011AA)
CL333417 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0025362 (UMLS CUI 2011AA)
91138005 (SNOMED CT 2011_0131)
10027378 (MedDRA 14.1)
F79 (ICD-10-CM Version 2010)
319 (ICD-9-CM Version 2011)
ergospirometry cannot be performed
Item
ergospirometry cannot be performed
boolean
C0085143 (UMLS CUI 2011AA)
C0037981 (UMLS CUI 2011AA)
127783003 (SNOMED CT 2011_0131)
10041629 (MedDRA 14.1)
C1882330 (UMLS CUI 2011AA)
C1518422 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
pregnancy
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
participation in a clinical trial within the last 4 weeks or current participation in a clinical trial (except studies of the Competence Network for Congenital Heart Defects)
Item
participation in a clinical trial within the last 4 weeks or current participation in a clinical trial (except studies of the Competence Network for Congenital Heart Defects)
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0086035 (UMLS CUI 2011AA)
32082000 (SNOMED CT 2011_0131)
C1882071 (UMLS CUI 2011AA)
C0018798 (UMLS CUI 2011AA)
13213009 (SNOMED CT 2011_0131)
10002626 (MedDRA 14.1)
Q24.9 (ICD-10-CM Version 2010)
746.9 (ICD-9-CM Version 2011)
diseases or functional disorders that exclude participation according to physician's convenience
Item
diseases or functional disorders that exclude participation according to physician's convenience
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0277785 (UMLS CUI 2011AA)
386585008 (SNOMED CT 2011_0131)
C0332196 (UMLS CUI 2011AA)
77765009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0680240 (UMLS CUI 2011AA)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0814633 (UMLS CUI 2011AA)
poor cooperation
Item
Uncooperative behavior
boolean
C0424350 (UMLS CUI 2011AA)
248042003 (SNOMED CT 2011_0131)
known or continuous drug or alcohol abuse
Item
known or continuous drug or alcohol abuse
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0750536 (UMLS CUI 2011AA)
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
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